Label: ARTHRITIS PAIN RELIEF- histamine dihydrochloride cream
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Contains inactivated NDC Code(s)
NDC Code(s): 83041-101-14 - Packager: PainX LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated November 7, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- USES
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WARNINGS
For external use only.
Do not use on wounds or damaged skin or if you are allergic to ingredients in the product.
When using this product avoid contact with eyes. If product gets into eyes, rinse thoroughly with water.
Do not bandage tightly or use a heating pad.
Stop using and ask doctor if- Rash appears.
- Condition worsens, if symptoms persists for more than 7 days, or if symptoms clear up and occur again within a few days.
- DIRECTIONS
- PREGNANCY
- KEEP OUT OF REACH OF CHILDREN
- OTHER INFORMATION
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INACTIVE INGREDIENTS
Water, Cetearyl Alcohol, Dimethicone, Caprylic/Capric Triglyceride, Stearyl Alcohol, Glycerin, Methylsulfonylmethane, Glyceryl Stearate, PEG-100 Stearate, Simmondsia Chinensis (Jojoba) Seed Oil, Carthamus Tinctorius (Safflower) Seed Oil, Emu Oil, Stearic
Acid, Tocopheryl (Vitamin E) Acetate, Glucosamine Hydrochloride, Phenoxyethanol, Menthol, Carbomer, Curcuma Longa (Turmeric) Root Extract, Chamomilla Recutita (Matricaria) Flower Extract, Aloe Barbadensis Leaf Juice, Triethanolamine, Ethyhexylglycerin, Disodium EDTA. - PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ARTHRITIS PAIN RELIEF
histamine dihydrochloride creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:83041-101 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HISTAMINE DIHYDROCHLORIDE (UNII: 3POA0Q644U) (HISTAMINE - UNII:820484N8I3) HISTAMINE DIHYDROCHLORIDE 0.03 g in 100 g Inactive Ingredients Ingredient Name Strength .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) MATRICARIA CHAMOMILLA FLOWERING TOP (UNII: 3VNC7T6Z02) JOJOBA OIL (UNII: 724GKU717M) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) STEARIC ACID (UNII: 4ELV7Z65AP) PHENOXYETHANOL (UNII: HIE492ZZ3T) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) DIMETHICONE (UNII: 92RU3N3Y1O) GLUCOSAMINE HYDROCHLORIDE (UNII: 750W5330FY) MENTHOL (UNII: L7T10EIP3A) CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) TURMERIC (UNII: 856YO1Z64F) TROLAMINE (UNII: 9O3K93S3TK) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) SAFFLOWER OIL (UNII: 65UEH262IS) GLYCERIN (UNII: PDC6A3C0OX) WATER (UNII: 059QF0KO0R) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) DIMETHYL SULFONE (UNII: 9H4PO4Z4FT) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) PEG-100 STEARATE (UNII: YD01N1999R) EMU OIL (UNII: 344821WD61) ALOE VERA LEAF (UNII: ZY81Z83H0X) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:83041-101-14 119 g in 1 JAR; Type 0: Not a Combination Product 11/07/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 11/07/2022 Labeler - PainX LLC (118688116) Registrant - PainX LLC (118688116)